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New device closes heart pouch to stop strokes without blood thinners

NCT ID NCT02681042

Disease control Sponsor: Baylor Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a device called the Lariat to close off a small pouch in the heart (the left atrial appendage) in people with atrial fibrillation who cannot take blood thinners. The goal was to reduce the risk of stroke. Nine participants were enrolled, and the study measured how well the device worked and how safe it was.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

9 people

The number who actually took part.

Started

Mar 2015

Finished

May 2018

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients aged ≥18 years * Patients able and willing to provide informed consent * Documentation of atrial fibrillation or atrial flutter * Clinical decision by the subject's physician that the patient is at risk for embolic stroke, and oral anticoagulant medications (OAC) is contraindicated * Hypertension, Abnormal renal and hepatic function, Stroke, Bleeding tendency/predisposition, Labile International Normalized Ratios (INRs) on warfarin (HAS-BLED) score \> 3 * Congestive Heart Failure (CHF), Hypertension, Age \>65, Diabetes Mellitus, Stroke or Transient Ischemic Attack (TIA), Vascular Disease, Age \>75, Sex Category (CHADS2-VASC) score \>3, OR CHADS2-VASC of 2 if physician provides justification for procedure * Anatomy favorable for deployment of the SentreHeart Lariat® Exclusion Criteria: * Medically unable to provide informed consent * Previous cardiothoracic surgery * Patient is a candidate for catheter or surgical ablation * Need for concomitant cardiac surgery procedure * Thrombus in the left atrial appendage or left atrium * Pregnancy

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Conditions

The condition(s) this trial relates to.

atrial fibrillation atrial flutter Embolic Stroke intracranial embolism prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation Cardioembolic stroke

Contacts and locations

Locations

  • Baylor Research Institute at The Heart Hospital Baylor Plano

    Plano, Texas, 75093, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.